JPAClass II

System, Multipurpose For In Vitro Coagulation Studies

21 CFR 864.5425 / Hematology

JPA is the FDA product code for System, Multipurpose For In Vitro Coagulation Studies, a class II device type, regulated under 21 CFR 864.5425. As of 2026-09-10, FDA records hold 181 510(k) clearances under this code, the most recent dated 2026-04-27, and 43 recalls.

Classification record

Product code: JPA
Device name: System, Multipurpose For In Vitro Coagulation Studies
Regulation: 21 CFR 864.5425
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 181
Ingested recalls: 43

Clearances, product code JPA

By decision year

181 clearances under product code JPA with a decision year between 1976 and 2026, 1985 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code JPA by decision year
Year	Clearances
1976	1
1977	7
1978	1
1979	4
1981	3
1983	2
1984	3
1985	13
1986	8
1987	10
1988	10
1989	4
1990	4
1991	2
1992	5
1993	9
1994	4
1995	7
1996	6
1997	3
1998	6
1999	4
2000	10
2001	4
2002	2
2003	3
2004	1
2005	5
2006	2
2007	1
2008	2
2009	6
2010	1
2011	1
2013	1
2015	2
2016	6
2017	4
2018	1
2019	3
2021	1
2022	1
2023	3
2024	1
2025	3
2026	1

Applicants with the most clearances

Product code JPA

Applicants holding the most 510(k) clearances under product code JPA
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	14
Bio/Data Corp.	13
Instrumentation Laboratory Co.	12
Accriva Diagnostics, Inc.	11
Helena Laboratories, Corp.	8
Sigma Diagnostics, Inc.	8
bioMerieux, Inc.	7
Siemens Healthcare Diagnostics Products Limited	6
Behring Diagnostics, Inc.	5
Diatech, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order